FDA Inspection
Aero HealthcareAero Healthcare – FDA Inspection, Nov 20, 2017
Record Details
This FDA Inspection record concerns Aero Healthcare, with an inspection on November 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ba045f65-7709-4059-900a-192b98e41bb2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1032208
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Aero Healthcare
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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